Safety and Effectiveness of an Adjuvant in Improving Immune Response to Hepatitis B Virus Vaccine in HIV Infected Individuals

• Quantitative hepatitis B surface antibody (HBsAb) [ Time Frame: At Week 16 ] [ Designated as safety issue: No ]
  
• Occurrence of Grade 3 or higher adverse events (including hypersensitivity reaction) related to study regimens and HIV viral load increase greater than 1 log(10) [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
  

• Quantitative HBsAb 24 and 48 weeks after completion of HBV vaccination series [ Time Frame: At Weeks 36 and 60 ] [ Designated as safety issue: No ]
  
• HBsAb response, defined as titer greater than 10 mlU/ml at 4, 24, and 48 weeks after completion of HBV vaccination series [ Time Frame: At Weeks 16, 36, and 60 ] [ Designated as safety issue: No ]
  
• Changes in HIV viral load from baseline [ Time Frame: At Weeks 4, 16, and 60 ] [ Designated as safety issue: No ]
  
• Changes in white blood cell and absolute neutrophil count from baseline [ Time Frame: At Weeks 4, 16, and 36 ] [ Designated as safety issue: No ]
  
• Occurrence of Grade 2 or higher adverse events [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
  
• Changes in CD4 count from baseline [ Time Frame: At Weeks 4, 16, and 60 ] [ Designated as safety issue: No ]
  

Highly active antiretroviral therapy (HAART) has greatly improved the life of HIV infected individuals. Before the introduction of HAART, the impact of HBV infection and liver disease was less prominent due to the rapid progression to AIDS. However, with the use of HAART, liver disease has become a leading cause of death in HIV infected individuals; therefore, prevention of HBV infection is essential. Most HIV infected people respond poorly to HBV vaccines. GM-CSF is a cytokine produced primarily by activated T and B cells and has been used extensively as a hematopoietic growth factor. GM-CSF increases neutrophil count, improves antigen-presenting cell function, and is involved in the development and improvement of cellular immune responses. Past research has shown that GM-CSF improves the immune response to HBV vaccination in people with kidney disease. The purpose of this study is to evaluate the safety and effectiveness of GM-CSF as an adjuvant to improve the immune response to HBV vaccination in HIV infected individuals.

This study will last 60 weeks. Participants will be randomly assigned to 1 of 2 arms. Arm A participants will receive 40 mcg of HBV vaccine at study entry, Week 4, and Week 12. Arm B participants will receive 40 mcg of HBV vaccine and 250 mcg of GM-CSF at study entry, Week 4, and Week 12. Participants will be stratified by their screening HIV-1 viral load. After completing the vaccination series, study visits will occur at Weeks 16, 36, and 60. Blood collection, a physical exam, and liver function and hepatitis antibody tests will be completed at all study visits. Telephone follow-up by study staff will occur 48 to 96 hours post-vaccination.